February 9, 2011
ASR™ Hip System Recall
In August 2010, DePuy Orthopaedics, Inc., issued a voluntary recall of the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System after new information from the UK National Joint Registry indicated that the number of patients who required a second hip replacement procedure, called a revision surgery, was higher than previously reported data.
ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System. The DePuy ASR™ Hip Resurfacing System was approved for use outside the U.S. and the ASR™ XL Acetabular System was available worldwide.
August 24, 2010
History of ASR hip system
The ASR Hip System was designed as an additional option for surgeons in treating patients suffering from severe and disabling arthritis and other diseases of the hip joint. The ASR Hip System was designed and developed in conjunction with experienced orthopaedic surgeons and leaders in the biomedical field.
The ASR Hip System was cleared for marketing by the U.S. Food and Drug Administration under the 510k regulatory process established by Congress, which is used for a majority of medical devices on the market.
The ASR Hip Resurfacing System was introduced outside the US in 2003. The ASR XL Acetabular System was introduced outside the US in 2004 and in the US in 2005.
Reason for Recall
In August 2010, DePuy announced a voluntary recall of the ASR Hip system after receiving new information from the UK National Joint Registry as part of its ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.
This data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was not in line with previously reported data.
DePuy's previous analyses of collective post-market data from a variety of sources – including national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports – had shown lower revision rates.
Number of ASR Patients
Approximately 93,000 worldwide
The ASR Hip System
The hip joint is like a ball that fits in a socket. The socket portion of the hip is called the acetabulum. The femoral head at the top of the thigh bone (femur) rotates within the curved surface of the acetabulum.
The ASR XL Hip System includes two components: the femoral head (or ball) fits inside the one piece metal acetabular cup which replaces the acetabulum.
With the DePuy ASR Hip Resurfacing system there are two components: a cap is placed over the natural femoral head and the acetabulum is replaced with the one-piece cup. All components for the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing Platform are part of this recall.
DePuy Hip Recall Lawsuit
By filing a DePuy hip recall lawsuit you may be able to recover financial compensation for pain and suffering, lost earnings, and medical bills.
For More Information
Contact the personal injury attorneys of Tremont Sheldon Robinson Mahoney for more information about the DePuy hip recall and lawsuit. Tremont Sheldon Robinson Mahoney has been serving the injured of Connecticut for over 50 years and has been recognized as a leader in personal injury. Contact Tremont Sheldon Robinson Mahoney to review your case and options.